August 2021: Nivolumab (Opdivo, Bristol-Myers Squibb Co.) Oziq -ovqat va farmatsevtika idorasi tomonidan radikal rezektsiyadan keyin qaytalanish xavfi yuqori bo'lgan urotelial karsinomali bemorlarni yordamchi davolash uchun tasdiqlangan.
Bu FDA birinchi marta yuqori xavfli bemorlar uchun yordamchi davolanishni ma'qulladi. Topilmalar, shuningdek, nivolumabning ilg'or/metastatik UC uchun tezlashtirilgan avtorizatsiyasini standart tasdiqlashga o'tkazish qarorini qo'llab -quvvatladi.
Nivolumab CHECKMATE-274 (NCT02632409) da o'tkazilgan, bu kasallik 120 kundan keyin takrorlanish xavfi yuqori bo'lgan siydik pufagi yoki yuqori siydik yo'llari (buyrak toslari yoki siydik pufagi) bilan og'rigan bemorlarda, randomizatsiyalangan, ikki marta ko'r, platsebo nazorati ostida o'tkazilgan. radikal rezektsiya. Bemorlarga tasodifiy tayinlangan (1: 1) 240 mg nivolumab yoki platsebo tomir ichiga infuziya orqali har ikki haftada takrorlanish yoki chidab bo'lmas toksiklikka qadar, maksimal davolash davri bir yil.
In the intent-to-treat (ITT) group and in patients with tumours expressing PD-L1 less than 1%, the primary effectiveness objective was investigator-assessed disease-free survival (DFS). Time to first recurrence (local urothelial tract, local non-urothelial tract, or distant metastatic) or death was used to determine DFS. For all primary objectives, a statistically significant improvement in DFS was reported in participants on the nivolumab arm vs. placebo at a prespecified interim analysis. In the ITT analysis, patients who got nivolumab had a median DFS of 20.8 months (95 percent CI: 16.5, 27.6) compared to 10.8 months (95 percent CI: 8.3, 13.9) in patients who received placebo (HR 0.70; 95 percent CI: 0.57, 0.86; p=0.0008). Patients who received nivolumab had a median DFS of not achieved (95 percent confidence interval: 21.2, not estimable) compared to 8.4 months (95 percent confidence interval: 5.6, 21.2) for those who got placebo (HR 0.55; 95 percent confidence interval: 0.39, 0.77; p=0.0005).
PD-L0.83-salbiy o'smalari (1 foiz) bilan og'rigan bemorlarni tekshirishda DFS xavf darajasi tasniflanmagan 58 (95 foiz CI: 0.64, 1.08). Barcha tasodifiy populyatsiyada o'limning 33 foizi bo'lsa ham, OS ma'lumotlari hali boshlanmagan. UTUC subpopulyatsiyasida 37 ta o'lim qayd etilgan (20 ta nivolumab qo'lida, 17 ta platsebo qo'lida).
CHECKMATE-20da nivolumab olgan ishtirokchilarning taxminan 274 foizida toshmalar, charchash, diareya, qichishish, mushak-skelet tizimining og'rig'i va siydik yo'llari infektsiyasi eng keng tarqalgan salbiy ta'sirlar bo'lgan.
Nivolumab har ikki haftada 240 mg dozada yoki har to'rt haftada 480 mg dozada UCni yordamchi davolash uchun buyuriladi.
Reference: https://www.fda.gov/
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